Tags: Coronavirus | Coronavirus Special | Health Topics | Trump Administration | cdc | fda | testing

CDC Lab Contamination Caused Testing Delay, HHS Probe Finds

a mock up for a coronavirus test laying on a facemask
(Oleksandr Lutsenko/Dreamstime)

By    |   Saturday, 18 April 2020 02:21 PM

The U.S. delay in getting adequate coronavirus testing across America has been determined to be contamination at the Centers for Disease Control and Prevention lab in Atlanta this January, The Washington Post reported.

CDC spokesman Benjamin Haynes confirmed in a statement to the Post, a "quality control" issue delayed getting the test kits out because they were delivering false positives. The CDC has since "implemented enhanced quality control to address the issue," Haynes confirmed.

Among the first 26 public health labs to get the test kits, 24 confirmed false negatives from purified water before testing patient samples, which has attributed to coronavirus contamination of the testing kits at the CDC lab, sources who spoke on the condition of anonymity, because they were not authorized to speak publicly, told the Post.

"Only two of them got it right," a senior federal scientist involved in the development and study of the initial test kits told the Post.

"The bottom line is, if you have a negative sample, and it's coming up positive, the only way for that to happen is cross contamination," the scientist added. "There is no other explanation for it."

The CDC violated their own manufacturing practices at a lab that was also handling synthetic coronavirus material, sources told the Post. The U.S. Food and Drug Administration confirmed the substandard practices found at the lab.

"CDC did not manufacture its test consistent with its own protocol," the FDA told the Post. "It's critical that the tests used work, because false results can also contribute to the spread of COVID-19."

The mixup delayed testing about one month, according to "an examination of federal documents and interviews with more than 30 present and former federal scientists and others familiar with the events," the Post reported.

Department of Health and Human Services is investigating the initial failures, federal officials said, and the CDC acknowledged test kits had "a design and/or manufacturing issue or possible contamination."

"With a negative control, there's nothing there to be amplified unless there was some contamination present," retired senior CDC microbiologist Stephen Morse told the Post. "If your negative control is giving you a positive reaction, that's indication of contamination."

The CDC mishap forced it to contract an independent contractor to manufacture the kits in late February, according to the report.

"I was just saddened and embarrassed when this test didn't work out," former CDC official James Le Duc, a virologist who now is director of the Galveston National Laboratory in Texas, told the Post. "It's really a terrible black mark on the CDC, and the impact was devastating to the country."

China publicly released COVID-19's genetic sequence Jan. 12, which is when the CDC Biotechnology Core Facility Branch lab in Atlanta got to work on developing the initial tests. The CDC elected to conduct a more thorough test than the World Health Organization kits, because it "may have hoped to bolster the kits' reliability in distinguishing COVID-19 from other coronavirus strains," according to the report.

"The first lot, they did not find any issues," the scientist who investigated the issue told the Post. "They used the same [genetic] sequence for the second lot. ... The second lot they manufactured ended up getting cross-contaminated.

"It's not the water that's contaminated. It's one of the reagents."

© 2021 Newsmax. All rights reserved.


   
1Like our page
2Share
US
The U.S. delay in getting adequate coronavirus testing across America has been determined to be contamination at the Centers for Disease Control and Prevention lab in Atlanta this January, The Washington Post reported.
cdc, fda, testing, contamination, lab, covid-19, false positives
546
2020-21-18
Saturday, 18 April 2020 02:21 PM
Newsmax Media, Inc.
 

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
America's News Page
© Newsmax Media, Inc.
All Rights Reserved